Cothera Receives ISO 13485 Certification

DALLAS--(BUSINESS WIRE)--Cothera LLC, a global medical device manufacturer, announced
today it has received ISO 13485:2012 certification. This independent
certification validates Cothera’s long-standing commitment to quality,
and affirms that Cothera’s quality management system provides a solid
foundation for its medical device initiatives.

The ISO 13485 certification covers the design and development,
production and distribution of Cothera’s medical devices including its
flagship product, the VPULSETM System. The certification
demonstrates that Cothera has successfully implemented a quality
management system that conforms to certain worldwide standards for
medical device and diagnostic manufacturing. “As an early-stage medical
device company, ISO 13485 certification represents a significant growth
milestone," said General Manager Howard Edelman. "This designation,
along with our recently awarded CE Mark, recognizes Cothera’s commitment
to provide our customers with outstanding, high quality products and
broadens our path to increase international sales.”

The VPULSE System combines deep vein thrombosis (DVT) prevention and
post-procedure rehabilitation, and places effective therapies and
significant convenience in the hands of patients. DVT is among the most
frequent hospital-acquired conditions. Though many professional
associations and hospitals have developed protocols designed to prevent
DVT and PE (pulmonary embolism), until now there hasn’t been an
economically feasible medical device that transitions from hospital to
home use thus allowing for continued patient compliance. Given the
majority of DVT episodes occur post-discharge, the VPULSE System is
available to help hospitals control readmission-related costs, while
supporting clinician treatment plans.

About Cothera LLC - Founded in 2012, Cothera is a division of
United Orthopedic Group Inc., based in Plano, Texas. The company was
formed in response to market demands for better options to help prevent
DVT and PE. The VPULSE System is sold internationally through medical
device distributors.